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FDA Staff: Merck Sleep Drug Effective; Safety Concerns With Higher Doses

Food and Drug Administration staff said a proposed sleep drug from Merck & Co. (MRK) was effective, but questioned the safety of the product's higher doses.Merck is seeking FDA approval of a drug called suvorexant to treat insomnia. The product will be reviewed Wednesday by the FDA's peripheral and central nervous system advisory committee. The agency released a preliminary review of suvorexant Monday in preparation for the meeting.The product was studied in more than 2,000 patients and one study followed patients for more than a year. FDA staff appeared to be in agreement that the studies showed suvorexant was effective at helping people fall asleep and then stay asleep. However, staff raised concerns about the safety of higher doses. The company is proposing two starting doses of the product, depending on age, and two higher doses of the drug.One medical officer wrote, "suvorexant is effective but not safe at the higher doses mainly studied," citing concerns about next-day driving im...

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